Methods and systems for cardiac valve delivery

ABSTRACT

The present invention provides systems and methods for the repair, removal, and/or replacement of heart valves. The methods comprise introducing a delivery system into the heart, wherein a prosthesis is disposed on the delivery member attached to the delivery system, advancing the prosthesis to the target site, and disengaging the prosthesis from the delivery member at the target site for implantation. The present invention also provides implant systems for delivering a prosthesis to a target site in or near the heart. In one embodiment of the present invention, the implant system comprises a delivery system, an access system, and a prosthesis.

REFERENCE TO RELATED APPLICATIONS

This application claims priority to Provisional Application Ser. No.60/702,892 filed Jul. 27, 2005; Provisional Application Ser. No60/717,879 filed Sep. 16, 2005; Provisional Application Ser. No.60/734,429 filed Nov. 8, 2005; Provisional Application Ser. No.60/740,694 filed Nov. 29, 2005; and Provisional Application Ser. No.60/762,909 filed Jan. 27, 2006; all of which are incorporated herein byreference

FIELD OF THE INVENTION

The present invention relates generally to methods and systems forcardiovascular surgery.

1. Background of the Invention

Various surgical techniques may be used to repair a diseased or damagedheart valve, such as annuloplasty (contracting the valve annulus),quadrangular resection (narrowing the valve leaflets), commissurotomy(cutting the valve commissures to separate the valve leaflets), ordecalcification of valve and annulus tissue. Alternatively, the diseasedheart valve may be replaced by a prosthetic valve. Where replacement ofa heart valve is indicated, the dysfunctional valve is typically removedand replaced with either a mechanical or tissue valve.

A number of different strategies have been used to repair or replace adefective heart valve. Open-heart valve repair or replacement surgery isa long and tedious procedure and involves a gross thoracotomy, usuallyin the form of a median sternotomy. In this procedure, a saw or othercutting instrument is used to cut the sternum longitudinally and the twoopposing halves of the anterior or ventral portion of the rib cage arespread apart A large opening into the thoracic cavity is thus created,through which the surgeon may directly visualize and operate upon theheart and other thoracic contents. The patient must typically be placedon cardiopulmonary bypass for the duration of the surgery.

Open-chest valve replacement surgery has the benefit of permitting thedirect implantation of the replacement valve at its intended site. Thismethod, however, is highly invasive and often results in significanttrauma, risk of complications, as well as an extended hospitalizationand painful recovery period for the patient.

Minimally invasive valve replacement procedures have emerged as analternative to open-chest surgery. Wikipedia Encyclopedia defines aminimally invasive medical procedure as one that is carried out byentering the body through the skin or through a body cavity oranatomical opening, but with the smallest damage possible to thesestructures. Two types of minimally invasive valve procedures that haveemerged are percutaneous valve procedures and trans-apical valveprocedures. Percutaneous valve procedures pertain to making smallincisions in the skin to allow direct access to peripheral vessels orbody channels to insert catheters. Trans-apical valve procedures pertainto making a small incision in or near the apex of a heart to allow valveaccess. The distinction between percutaneous valve procedures andminimally invasive procedures is also highlighted in a recent positionstatement of the Society of Thoracic Surgeons (STS), the AmericanAssociation for Thoracic Surgery (AATS), and the Society forCardiovascular Angiography and Interventions (SCAI; Vassiliades Jr. T A,Block P C, Cohn L H, Adams D H, Borer J S, Feldman T, Holmes D R, LaskeyW K, Lytle B W, Mack M F, Williams D O. The clinical development ofpercutaneous heart valve technology: a position statement by the Societyof Thoracic Surgeons (STS), the American Association for ThoracicSurgery (AATS), and the Society for Cardiovascular Angiography andInterventions (SCAI). J Thorac Cardiovasc Surg. 2005; 129:970-6).Because minimally invasive approaches require smaller incisions, theygenerally allow for faster patient recovery with less pain and bodilytrauma. This, in turn, reduces the medical costs and the overalldisruption to the life of the patient.

The use of minimally invasive approaches, however, introduces newcomplexities to surgery. An inherent difficulty in the minimallyinvasive percutaneous approach is the limited space that is availablewithin the vasculature. Unlike open heart surgery, percutaneous heartsurgery offers a surgical field that is only as large as the diameter ofthe blood vessel used for access. Consequently, the introduction oftools and prosthetic devices becomes a great deal more complicated ascompared to open-chest surgeries. The device must be dimensioned andconfigured to permit it to be introduced into the vasculature,maneuvered therethrough, and positioned at a desired location. This mayinvolve passage through significant convolutions, at some distance fromthe initial point of introduction, before placement can be made at theintended site.

Andersen et al. describe a valve prosthesis implanted in a body channelby a way of catheterization in U.S. Pat. Nos. 5,411,442; 5,840,081;6,168,614; and 6,582,462; and U.S. patent application Ser. No.10/268,253, hereby incorporated by reference in their entirety.Catheters are hollow flexible tubes which can be passed inside bloodvessels to the heart for diagnostic and treatment purposes. The deliveryof catheter expanded valves through body channels such as that describedby Andersen et al. is thus dependent on instruments of sufficientlysmall diameters, as well as adequate length and flexibility to navigateblood vessels.

Minimally invasive trans-apical valve replacement procedures haveemerged as an alternative to both open-chest surgery and percutaneousvalve surgeries. Bergheim et al. present improved methods and systemsfor cardiac valve delivery in U.S. patent application Ser. Nos.60/702,892 and 10/831,710, hereby incorporated by reference in theirentirety. Methods and systems for the repair, removal, and/orreplacement of heart valves through the apex of the heart are described.This is an improvement over minimally invasive percutaneous approachesattempting insertion into the vasculature as the trans-apical approachis not limited by the space that is available within the vasculature.Trans-apical delivery is also closer to the heart than catheter-basedprocedures.

In-vivo studies have shown that catheter-based valve deliveryinstrumentation may not be well adapted for trans-apical procedures.When inserting balloon catheters, as described in U.S. Pat. No.6,582,462 and U.S. patent application Ser. No. 10/831,770, it isdifficult to steer the balloon and the valve into position resultingfrom the lack of rigidity and the inherent flexibility of catheters.This is especially true in minimally invasive trans-apical valveprocedures. By their very nature, catheters are designed to be long,flexible and bendable to navigate long distances through thevasculature. Catheters are also frequently susceptible to twisting. As aresult, catheters are typically thin and made of flexible materials suchas plastics or polymers. Catheters are also designed to be disposed onguidewires to better direct the catheter to the correct location. Evenso, it is difficult to steadily and accurately deliver tools and devicesover long distances. This is especially true in high flow situationssuch as a beating heart and in places offering the catheters asubstantial amount of space to move within. Correct and accurateplacement of a heart valve requires both accurate longitudinalpositioning as well as rotational positioning. It is important tocorrectly place the valve as much as possible into a position thatmimics that of the native valve to maximize durability and function. Itis also important to prevent placement of the valve in a manner thatblocks the left and right coronary outflow (as in the case of the aorticvalve). There is hence a need to accurately maneuver and steer the valveduring implantation. There is also a need for a device that is moresuitable for delivering valves during trans-apical procedures.

During balloon-inflation of a flexible leaflet valve, such as a stentedtissue valve, it is desired that the valve remain on the balloon untilit is firmly positioned at the site of implantation. In the case ofballoon-expandable valves, there is hence a need for devices designed tomake sure the valve stays on the balloon during inflation.

Bergheim further presents methods and assemblies for distal embolicprotection in U.S. patent application Ser. No. 10/938,410, herebyincorporated by reference in its entirety. Here, Bergheim describesdistal embolic protection assemblies for use during trans-apical valvesurgery. In order to accommodate a distal embolic protection assemblyalongside other valve insertion and replacement devices, it is importantthat the distal embolic protection assembly collapses down to asubstantially small diameter to minimize the space it occupies

Macoviak et al. present a filter catheter used to capture potentialemboli within the aorta during heart surgery and cardiopulmonary bypassin U.S. patent application Ser. No. 10/108,245, hereby incorporated byreference in its entirety. The filters described by Macoviak are adaptedfor use during cardiopulmonary bypass, and not during beating heartsurgery. The filters described by Macoviak are also intended to beinserted through the femoral artery and further fail to incorporate atemporary valve, useful for capturing large amounts of debris whileperforming beating heart surgeries. There is hence a need for a filtersystem better suited for percutaneous and trans-apical valve surgeries.

Accordingly, while open-heart surgery produces beneficial results formany patients, numerous others who might benefit from such surgery areunable or unwilling to undergo the trauma and risks of currenttechniques. Therefore, what is needed are methods and devices forperforming heart valve repair and replacement as well as otherprocedures within the heart and great vessels of the heart that providegreater ease of access to the heart valves than the current minimallyinvasive techniques, while at the same time reducing the trauma, risks,recovery time and pain that accompany more invasive techniques.

SUMMARY OF THE INVENTION

The present invention provides methods and systems for performingcardiovascular surgery, wherein access to the heart or great vessels isprovided through the heart muscle. In preferred embodiments, access isprovided through the apical area of the heart. The apical area of theheart is generally the blunt rounded inferior extremity of the heartformed by the left and right ventricles. In normal healthy humans, itgenerally lies behind the fifth left intercostal space from themid-sternal line.

The unique anatomical structure of the apical area permits theintroduction of various surgical devices and tools into the heartwithout significant disruption of the natural mechanical and electricalheart function. Because the methods and systems of the present inventionpermit direct access to the heart and great vessels through the apex,they are not limited by the size constraints which are presented byminimally invasive percutaneous valve surgeries. While access to theheart through peripheral (e.g. femoral, jugular, etc) vessels inpercutaneous methods are limited to the diameter of the vessel(approximately 1 to 8 mm), access to the heart through the apical areais significantly larger (approximately 1 to 25 mm or more). Thus, apicalaccess to the heart permits greater flexibility with respect to thetypes of devices and surgical methods that may be performed in the heartand great vessels.

Accordingly, it is one object of this invention to provide methods anddevices for the repair, removal, and/or replacement of valves or theirvalve function by access through the heart muscle, particularly throughthe apical area of the heart. It should be noted that while reference ismade herein of trans-apical procedures, it is intended for suchprocedures to encompass access to the heart through any wall thereof,and not to be limited to access through the apex only. While the apicalarea is particularly well suited for the purposes of the presentinvention, for certain applications, it may be desirable to access theheart at different locations, all of which are within the scope of thepresent invention.

In one embodiment of the present invention, a method for delivering aprosthesis to a target site in or near a heart is provided. The methodcomprises introducing a delivery system into the heart, preferably at ornear the apex of the heart, wherein a prosthesis is disposed on thedelivery member attached to the delivery system, advancing theprosthesis to the target site, and disengaging the prosthesis from thedelivery member at the target site for implantation. In anotherembodiment of the current invention, a method for delivering aprosthesis to a pre-existing man-made valve within or near a heart isprovided.

The present invention also provides an implant system for delivering aprosthesis to a target site in or near a heart. In one embodiment of thepresent invention, the implant system comprises a delivery system, anaccess system, and a prosthesis. In one embodiment of the presentinvention, the access system is a trocar, cannula, or other suitabledevice to penetrate the heart, preferably at or near the apex of theheart; and the delivery system is substantially rigid and movablydisposed within the trocar, wherein a prosthetic valve is disposed onthe delivery member attached to the delivery system. In one embodimentof the present invention, the delivery system is termed a Scapus™system. The term “Scapus™” denotes a slender or elongated rod shapedsupport structure that is substantially rigid. The term substantiallyrigid implies structural stability to withstand fluid pressures andother forces without unintended deformation. On the other hand, the.Scapus™ may encompass junctions or other means of controlled bending toallow for directional control by the operator at predetermined pointsalong the length of the Scapus™. In one embodiment of the currentinvention, the delivery system comprises a Scapus™ and a deliverymember.

The delivery system may be used to deliver a variety of prosthetic heartvalves, including stented and stentless tissue valves. In one embodimentof the present invention, the delivery member comprises a mechanical orinflatable expanding member to facilitate implantation of the prostheticvalve at the target site. In another embodiment of the presentinvention, the delivery member is a balloon. In another embodiment ofthe present invention, the delivery member is a device used to expandfolded valves. In yet another embodiment of the present invention, thedelivery member may comprise an inflatable balloon member, whose distaland proximal ends have substantially larger cross-sectional areas thanthe portion of the balloon covered by the prosthesis, to preventprosthesis migration. In a further embodiment of the present invention,the delivery system may comprise a duct or perfusion tube to allow bloodflow through the delivery member during the procedure.

It is a further object of the current invention to provide systems andmethods for converting a catheter into a Scapus™ delivery system. In oneembodiment of the current invention, a substantially thin, stiffguide-stick is inserted into the catheter to give it similarcharacteristics as a Scapus™. In another embodiment of the currentinvention, a substantially thin, stiff guide-sleeve slides on theoutside of a catheter to give it similar characteristics as a Scapus™.

The delivery systems described herein may be used to deliver prostheticvalves to all four valves of the heart including the aortic valve,mitral valve, tricuspid valve, and pulmonary valve. Different anatomicalfeatures for the different heart valves (bicuspid vs. tricuspid valves)may call for different design heart valves. Therefore, in one embodimentof the present invention, the prostheses are designed to match theanatomy of the target valve position. In another embodiment of thecurrent invention, the prosthesis is composed of a tissue valve mountedin a stent.

One group of patients that will benefit from a trans-apical procedure ispatients who have had previous valve replacements, and where replacementvalves are failing. Rather than performing yet another open-chestprocedure, many of these patients may be candidates for trans-apicalvalve replacements. This is especially the case for older patients whomay not tolerate the stress of a new open-chest procedure. For thesepatients, who have a failing valve, one may seat the new trans-apicaldelivered prosthesis inside the failing valve. Therefore, in oneembodiment of the present invention, the new prosthesis matches theconfiguration of the failing valve. Some patients who have had previousvalve replacements, and whose valve replacement valves are failing mayalso be candidates for percutaneous valve procedures. For thesepatients, who have a failing valve, one may seat the new percutaneouslydelivered prosthesis inside the failing valve.

The present invention also provides for devices and methods forproviding distal embolic protection and a temporary valve. In oneembodiment of the present invention, the distal embolic protectionsystem provides a filter member for trapping embolic material thatconcurrently functions as a temporary valve. The filter and temporaryvalve assembly prevents flush back of embolic material and debris, whilestill allowing fluid flow into the filter during surgery. Thevalve-filter combination may be compressed and expanded to allow entryinto small blood vessels or other body cavities. In one embodiment ofthe present invention, the filter assembly is implanted in the heart orgreat vessel of the heart, downstream from the surgical site.

In one embodiment of the present invention, a valvuloplasty balloon isinflated to increase the effective orifice area of a heart valve. Inanother embodiment of the present invention, the valvuloplasty balloonslides over the guide wire or actuation sleeve connected to the distalembolic protection device.

Since a transapical procedure does not provide direct line of sight,sufficient imaging of the heart, valves, and other structures isimportant to provide diagnostics, guidance and feed-back during theprocedure. A Scapus™ delivery system may be of a larger diameter thanthat of a catheter and is thus better suited for containing imagingtransducers. Thus in one embodiment of the present invention, an imagingtransducer is placed onto the delivery system. In another embodiment ofthe present invention, an external imaging transducer may be provided toview the operating field. Imaging systems may be used at any time orthroughout the duration of the surgery. Imaging systems are well-knownto those skilled in the art and include transesophageal echo,transthoracic echo, intravascular ultrasound imaging (IVUS),intracardiac echo (ICE), or an injectable dye that is radiopaque.Cinefluoroscopy may also be utilized.

In another embodiment of the present invention, a positioning balloon isused to help position the Scapus™ correctly such that the new prosthesis(or alternatively other tools) land in the proper location.

In yet another embodiment of the present invention, method and systemmay further comprise means to remove at least a portion of the patient'sheart valve by a cutting tool that is disposed on the delivery system.

In a further embodiment of the present invention, the methods anddevices of the present invention may be adapted to provide a valvedecalcification system, wherein the delivery system is capable ofproviding a dissolution solution to the treatment site by access throughthe apical area of the heart. The delivery system may be a catheter or aScapus™ that is configured with means to both introduce and remove thedissolution solution to the treatment site. The delivery system may alsoprovide means for isolating the treatment site to prevent thedissolution solution from entering into the patient's circulatorysystem. Such means for isolating the treatment site may include abarrier, such as a dual balloon system on the catheter that inflates onboth sides of the treatment site.

The present invention provides methods and systems for creating acalcified animal model for use in the development and testing of cardiacvalves.

Although many of the above embodiments are referenced with respect tothe aortic valve in the heart, the current invention may also beutilized for procedures related to the mitral valve, tricuspid valve,and the pulmonary valve.

The above aspects and other objects, features and advantages of thepresent invention will become apparent to those skilled in the art fromthe following description of the preferred embodiments taken togetherwith the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial front view of a patient's chest showing a prosthesisintroduced into the apex of the heart through the fifth intercostalspace using an implant system.

FIG. 2 depicts a linear penetrating the apex of the heart and into theleft ventricle.

FIG. 3 shows two independent balloon delivery members contained on theScapus™ delivery system for providing both valvuloplasty and valvedelivery.

FIG. 4 shows a prosthetic valve disposed onto a “dog-bone” shapedballoon.

FIG. 5 shows a Scapus™ delivery system and a distal embolic protectionassembly.

FIG. 6 shows a Scapus™ delivery system and a distal embolic protectionassembly.

FIG. 7 shows the distal embolic protection system positioned in theaorta and inserted through the femoral artery.

FIG. 8 shows a prosthetic valve implanted in the heart.

FIG. 9 shows a Scapus™ delivery system.

FIG. 10 shows a Scapus™ delivery system.

FIG. 11 shows a close-up of a balloon delivery member of a Scapus™delivery system.

FIG. 12 shows a distal embolic protection subsystem.

FIG. 13 shows a temporary valve distal embolic protection system.

FIG. 14 shows a dual balloon system for providing a valvedecalcification system.

FIG. 15 shows an exploded view of a heart valve implanted inside apreviously implanted heart valve.

FIG. 16 shows an a heart valve implanted inside a previously implantedheart valve.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 1 through 16 show embodiments of the methods and systems of thepresent invention for the repair, removal and/or delivery of prostheticvalves, and also for providing distal embolic protection and a temporaryvalve during cardiovascular procedures.

Valve Delivery Method and Implantation System

FIG. 1 is a partial front view of the chest 11 of a patient 10 and showsthe position of a surgical tool 29 in relation to other anatomicallandmarks, such as the sternum 13, xiphoid 14, ribs 15, and heart 12. Asurgical tool 29 is depicted as entering the body cavity through thefifth intercostal space 16 and through the apex of the heart 12. Thesurgical tool 29 is seen inserted through an access system 31. Thesurgical tool 29 may contain devices or systems used for surgicalprocedures in or on the heart or the greater vessels of the heart. Inone embodiment of the current invention, the surgical tool 29 is adelivery system. In another embodiment of the current invention, thesurgical tool 29 may be a distal embolic protection device. The surgicaltool 29 may enter the body cavity through various other locations 17A,17B and 17C, in the chest 11. In another embodiment of the currentinvention, the surgical tool 29 may be a plurality of devices. In oneembodiment of the current invention, the surgical tool 29 is both adelivery system and a distal embolic protection system.

In one embodiment of the present invention, the implant system comprisesan access system, delivery system, and a prosthesis. In one embodimentof the current invention, the prosthesis is a heart valve prosthesis. Inanother embodiment of the current invention, the access system 31 is atrocar, cannula, or other suitable device for penetrating the apex 18 ofthe heart 12. In another embodiment of the current invention, thedelivery system is composed of a delivery member, wherein the prostheticvalve is disposed on the delivery member. In another embodiment of thecurrent invention, the delivery system is substantially rigid. In yetanother embodiment of the current invention, the substantially rigidsupport structure of the delivery system is called a Scapus™. Inherentin its definition, the term Scapus™ implies a rigid support structurewith other devices, tools, and assemblies attached to it. In oneembodiment of the current invention, the delivery member of the deliverysystem is attached to the Scapus™.

The delivery system described in the current invention presents majoradvances over the use of catheters as delivery systems for procedures inclose vicinity of the heart. By their very nature, catheters aredesigned to be flexible to navigate long distances. Catheters must alsobe able to twist and bend to move through bends in the vasculature, suchas those encountered in percutaneous procedures. Catheters are alsodesigned to be disposed on guidewires to better direct the catheter tothe correct location. Even with the use of guidewires, it is difficultto steadily and accurately deliver tools and devices over longdistances. This is especially true in high flow situations such as abeating heart procedure. Correct and accurate placement of a heart valverequires both accurate longitudinal positioning as well as rotationalpositioning. It is important to correctly place the valve as much aspossible into a position that mimics that of the native valve tomaximize durability and function. It is also important to preventplacement of the valve in a manner that blocks the left and rightcoronary outflow (as in the case of the aortic valve).

Accurate delivery of cardiac valves in trans-apical procedures requiresaccurate and precise longitudinal and rotational positioning.Longitudinal positioning implies positioning along the length of theaorta. Rotational positioning implies rotational positioning around thelengthwise direction of the aorta. The route from the apex of the heartto all four cardiac valves is also a substantially straight line,meaning that the maneuvering features such as bending, twisting, andtorsion of a catheter are not typically desired. In fact, the inherentmaneuvering features of a catheter are disadvantageous in this procedureas it allows bending and torsion and is not able to hold the deliverymember in place during valve implantation. The blood flow and pressureinherent in a beating heart procedure in combination with a catheterdelivery system therefore does not allow accurate and precise deliveryof prosthetic valves.

An object of the present invention is therefore to provide a deliverysystem that is substantially rigid to resist any unintended bending andtorsion. A Scapus™, in contrast to a catheter, provides sufficientrigidity to accurately and precisely deliver a prosthesis during abeating heart procedure. A Scapus™ delivery system is designed not twistor bend unless intended by the operator. The Scapus™ of the presentinvention can incorporate junctions or other means of bending atpredetermined points to allow the operator to adjust the direction orangle of the delivery path in a controlled fashion.

In one embodiment of the present invention, the Scapus™ provides rigidsupport between the operator and the distal portion of the deliverysystem located in the heart. In contrast to catheter delivery systems, aScapus™ delivery system may incorporate a larger cross-sectional areasince access through the heart walls provides a larger access portdiameter (in some instances up to 25 mm or more) compared with thevasculature (0 to 8 mm or less).

In one embodiment of the current invention, the Scapus™ is made of amaterial that substantially resists bending and torsion. One example ofsuch a material is stainless steel or substantially strong polymerplastics.

In one embodiment of the current invention, the Scapus™ is a solid rod.In yet another embodiment of the current invention, the Scapus™ is ahollow rod. A Scapus™ may contain one or more lumens for moving fluid. AScapus™ may also contain actuating members such as rods, wires,guidewires, or catheters. A Scapus™ may also conduct or transmitelectricity or electrical signals and may also transmit light or lightsignals. A Scapus™ may also transmit radiation or other forms of energysuch as ultrasound, ultraviolet light, infrared light, or gamma rays.

A catheter used for percutaneous valve procedures are typically longerthan 50 cm to navigate through the vasculature. By contrast, the Scapus™length can be less than 50 cm. In preferred embodiments of the presentinvention, the length of the Scapus™ can be about 15-30 cm in total, ofwhich about 10 cm may be inserted into heart, and the remaining lengthleft outside.

The methods and systems of the present invention may be used to implanta variety of heart valve prosthesis known in the art, including stentedand stentless tissue valves. The methods and systems of the presentinvention may also be used to implant a variety of stents. In oneembodiment of the present invention, the prosthetic delivery member islocated towards the distal end of the delivery system. Stented valvesmay be expandable by mechanical or balloon expansion devices, or theymay be self-expanding. Self-expanding stents may be constructed fromelastic materials such as memory shaped metal alloys. An example of amemory shaped metal alloy is that of Nitinol. The valves are expandedusing the valve expansion member located on the delivery system. In oneembodiment of the present invention, the delivery member is amechanically actuated device used to expand stented valves. In anotherembodiment of the current invention, the delivery member is a balloonexpansion device. In another embodiment of the present invention, thedelivery member is a balloon used for radial expansion. In yet anotherembodiment of the current invention, the delivery member contains aself-expandable heart valve. There are numerous methods and systems forreleasing a self-expandable heart valve. One example in U.S. Pat. No.6,682,558, hereby incorporated by reference in its entirety.

Stented valves may also be expandable by unfolding the valve. The valvemay be unfolded by using a balloon or mechanical expansion device.Alternatively, the folded valves may be self-expanding. Self-expandingstents may be constructed from elastic materials such as memory shapedalloys. The valves are expanded using the valve expansion member locatedon the delivery system. In one embodiment of the present invention, thedelivery member is a mechanically actuated device used to expand stentedvalves that have been folded. In another embodiment of the currentinvention, the delivery member is a balloon expansion device. In such anembodiment, the balloon and stented valve have been folded together.When inflated, the balloon and stented valve return to their originalshape. When unfolding a stented valve using a mechanical expansiondevice or a balloon, the stent making up the stented valve is typicallymade from a non-memory shaped alloy. Examples of suitable materialsinclude stainless steel, polymers, plastics, and non-memory shapedmetals. In another embodiment of the present invention, the deliverymember is used to unfold stented valves made from memory shaped alloys.In one embodiment of the present invention, the delivery member consistsof a hollow tube in which the stented valve is placed into and a plateor actuating mechanism just proximal to the valve used to push out thevalve out of the hollow tube.

Alternatively, the methods and devices of the present invention may alsobe used to implant a stentless prosthetic heart valve. In one embodimentof the present invention, the delivery member is adapted to position thetissue valve at the target site and the deliver member further comprisesa means to suture or staple the tissue valve to the valve annulus.

Examples of suitable prosthetic valves are disclosed in the followingcommonly owned patents: U.S. Pat. Nos. 6,682,559; 5,480,424; 5,713,950;5,824,063; 6,092,529; 6,270,526; 6,673,109; 6,719,787; 6,719,788; and6,719,789, incorporated herein by reference. Examples of other valveassemblies suitable for use in connection with the present invention aredescribed in U.S. Pat. Nos. 5,411,552; 6,458,153; 6,461,382; and6,582,462, incorporated herein by reference. Yet another valve suitablefor use in connection with the present invention is disclosed in U.S.patent application Ser. No. 10/680,071, hereby incorporated forreference in its entirety.

Access systems suitable for use in connection with the present inventiontypically comprise a hollow lumen and a first and second ends. In oneembodiment of the present invention, the access system 31 is a trocar.The first end comprises a means for penetrating the heart tissue and thesecond end comprises a port through which the valve delivery system maybe introduced into the hollow lumen of the trocar and into the heart.FIG. 2 depicts an access system 31 penetrating through the apex 18 ofthe heart 12. The moving direction of the access system 31 as indicatedby the arrow 19. The access system 31 can enter either the rightventricle 20 or the left ventricle 21. To access the aortic or mitralvalve, the trocar 31 would preferably pass through the left ventricle21. This yields direct access to the aortic or mitral valve. To accessthe pulmonary or tricuspid valve, the trocar 31 would preferably passthrough the right ventricle 20.

In another embodiment of the present invention, the access system 31further comprises a valve disposed within its lumen. The valve isdesigned to reduce significant backflow of blood out of the heart 12after the access system 31 is inserted into the beating heart 12, whileat the same time permitting the introduction of the delivery member andother surgical devices in through the access system 31. Other suitableaccess systems 31 and devices are well known in the art and aredisclosed in U.S. Pat. Nos. 5,972,030; 6,269,819; 6,461,366; 6,478,806;and 6,613,063, incorporated herein by reference.

In one embodiment of the present invention, the operator places apursestring suture on the apex 18 of the heart 12 to create a sealaround the access system 31. Another embodiment of the present inventionallows the use of the Scapus™ delivery system without an access system31. It is contemplated that the physician becomes familiar with theadvantages of the present invention and thus may find it unnecessary touse a trocar. In the latter case, the distal embolic protection systemand the delivery system is placed directly through an incision in theapex 18 or other area of the heart wall. In another embodiment of thecurrent invention, a delivery sleeve or delivery sheath is placed on thedelivery system.

In one embodiment of the present invention, an off-the-shelfvalvuloplasty balloon catheter is introduced through the access system31 into the apex 18 of the heart 12, positioning the balloon of thecatheter within the valve and valve annulus. Valvuloplasty balloons arewell known to anyone skilled in the art. Once the balloon is placedwithin the valve, it may be inflated to widen a stiff or narrowed heartvalve (stenotic heart valve) improving blood flow through the heart andto the rest of the body. Previous methods for performing valvuloplastyrequired the insertion of a catheter typically through the femoralartery or femoral vein which is then guided through the heart andpositioned through the diseased heart valve. The methods and devices ofthis present invention, however, provide a more direct route to thevalve to be treated.

In another embodiment of the present invention, the delivery member ofthe delivery system described in the current invention is used tovalvuloplasty the diseased valve. In such an embodiment, the deliverymember of the delivery system is first guided to the diseased heartvalve and positioned within the valve and valve annulus. After expandingthe valve orifice, the delivery system is withdrawn from the accesssystem 31 and a new prosthetic valve is placed onto the valve deliverysystem. The valve delivery system is further introduced through theaccess system 31 and the delivery member moved into position within thevalve orifice to expand and implant the valve.

In yet another embodiment of the present invention, two independentdelivery members are contained on the delivery system. Such a system isshown in FIG. 3. Here, the delivery system 67 includes a Scapus™ 46, aperfusion tube 49, and two independently operated balloon deliverymembers 90 and 91. Such a configuration allows the delivery system 67 tobe used both for valvuloplasty and valve delivery. In such anembodiment, the most distal delivery member 91 is first guided to thediseased heart valve and positioned within the valve and valve annulus.After expanding the valve orifice, the delivery system 67 is moved suchthat the second most proximal delivery member 90, onto which theprosthetic valve is placed, is moved within the valve and valve annulusto expand and implant the valve. In a further embodiment of the presentinvention, no perfusion tube 49 is present and the balloons 90 and 91are in intimate contact with the Scapus™ 46. The use of two balloons 90and 91 as shown in FIG. 3 is not only practical in trans-apical valveprocedures, but also in percutaneous valve procedures. Thus, in oneembodiment of the present invention, the Scapus™ 46 shown in FIG. 3 is acatheter. In a further embodiment of the foregoing embodiment, thecatheter is a multilumen catheter.

Balloon Systems and Implantation Methods Thereof

Regardless of the type of valve delivery member utilized, it isimportant that the prosthetic valve remain securely attached to thedelivery member during implantation. This is especially true if theoperator accidentally or intentionally lowers the pressure in theballoon (via a syringe, etc). Thus, the present invention furtherprovides balloons that are shaped such that the distal and proximal endsof the balloon, not covered by the prosthetic valve, are larger in area,and thus prevents migration of the valve. Such a balloon may take theshape of a “dog-bone”.

FIG. 4 shows a balloon 50 delivery member whose proximal end 70 anddistal end 71 have a larger cross sectional area than the middle portionof the balloon in intimate contact with the prosthetic valve 100. FIG. 4also shows a perfusion tube 49 extending through the balloon from theproximal end 70 to the distal end 71 of the balloon delivery member 50allowing fluid to flow through the length of the balloon delivery member50. In one embodiment of the present invention, the balloon deliverymember 50 does not contain a perfusion tube 49. The orientation of theprosthetic valve 100 on the balloon delivery member 50 shown in FIG. 4in relation to the proximal end 70 and distal end 71 of the balloondelivery member 50 depends on the implantation method in relation tot heblood flow direction through the native valve. The orientation shown inFIG. 4 is preferred for apical implantation. In another embodiment ofthe present invention, the prosthetic valve 100 is oriented the oppositedirection on the balloon delivery member 50.

In one embodiment of the present invention, the distal end 71 andproximal end 70 of the balloon delivery member 50 has a material coatingthat has a larger coefficient of friction with the prosthetic valve asopposed to the middle portion of the balloon delivery member 50. In thecase of a balloon delivery member 50, an example of a material that hasa larger coefficient of friction with a prosthetic valve as compared tothe balloon is cloth. Increasing the roughness in the plastic making upthe balloon will also increase the coefficient of friction with theprosthetic valve.

The “dog-bone” shape balloon delivery member 50 described herein is notlimited to Scapus™ delivery systems. Such balloons can be utilized inany type of stent delivery. Thus, in one embodiment of the presentinvention, the “dog-bone” balloon delivery member 50 described hereinmay be utilized in any type of stent or prosthetic valve deliverysystem. In one embodiment of the present invention, the “dog-bone”balloon delivery member 50 is utilized on a catheter valve deliverysystem, such as those used for percutaneous valve delivery.

Delivery System and Methods

FIG. 5 depicts a delivery system 67 consisting of a Scapus™ 46, ballooninflation tube 45, proximal balloon delivery member connector 48, distalballoon member connector 51, perfusion tube 49, and a balloon deliverymember 50. In a preferred embodiment of the present invention, theproximal balloon delivery member connector 48 and the distal balloondelivery member connector 51 have a hole or a plurality of holesallowing blood to flow through the perfusion tube 49 and hence throughthe balloon delivery member 50. In another preferred embodiment, theScapus™ 46 comprises a substantially rigid solid rod. In one embodimentof the present invention, the Scapus™ 46 and the balloon inflation tube45 are glued or fused together at a plurality of points along the extentof the Scapus™ 46. In another embodiment of the present invention, theScapus™ 46 contains one or more inside lumens. In yet another embodimentof the current invention, the balloon inflation tube 45 is disposedwithin the Scapus™ 46. In another embodiment of the current invention,the balloon inflation tube 45 is one of the internal lumens of theScapus™ 46. In yet another embodiment of the current invention, theScapus™ 46 may be bent in a controlled fashion, using a bending force.As used herein, bending force here means bending moment that can becreated by the user of the operators' hands. The Scapus™ 46 cannot bebent by the much smaller forces imposed by the blood flow and thebeating heart. The Scapus™ 46 may further incorporate junctions or otherbending means that allow for operator-controlled bending of the Scapus™46 at predetermined points.

FIG. 5 also shows a distal embolic protection assembly 68. The distalembolic protection assembly consists of a frame 55 and a porous bags 56.In one embodiment of the present invention, the distal inlet portion ofthe filter mouth 53 includes a temporary valve.

In one embodiment of the present invention, the delivery system 67 isinserted through the trocar 31 into the left ventricle 21 and advancedtowards the native aortic valve of the heart 12. The delivery system 67may be composed of a substantially rigid Scapus™ 46 and a deliverymember. The heart valve prosthesis 100 is disposed around the balloondelivery member 50 and delivered to the target site for implantation.The length of balloon delivery member 50 suitable for the purposes ofthe present invention will depend on the height of the prosthetic valve100 to be implanted.

FIG. 6 shows a delivery system 67 comprising a perfusion tube 49,balloon delivery member 50, and a Scapus™ 46. Here, the Scapus™ 46 isrigidly attached to the perfusion tube 49. In one embodiment of thecurrent invention, the Scapus™ 46 has a lumen that extends to theballoon delivery member 50 and serves to inflate and deflate theballoon. The actuation sleeve 43 and guidewire 41 is loosely disposedwithin the perfusion tube 49.

In one embodiment of the present invention, the distal embolicprotection assembly 68, actuation sleeve 43 and guidewire 41 withinactivation sleeve 43 is movably disposed within the Scapus™ 46 of thedelivery system 67 and balloon delivery member 50 shown in FIG. 6. Inyet a further embodiment of the present invention, the distal embolicprotection assembly 68 may be collapsed and moved through the Scapus™ 46and balloon delivery member 50. In one embodiment of the presentinvention, the delivery system shown in FIG. 6 is inserted through thetrocar 31 in two steps: first the distal embolic protection assembly 68;second the delivery system 67 and balloon delivery member 50. Afterhaving introduced the trocar 31 through the apex 18 of the heart 12, thedistal embolic protection assembly 68 is moved in a collapsedconfiguration through the trocar 31 and the left ventricle 21 and placeddownstream from the aortic valve. Once the distal embolic protectionassembly 68 is in position, the distal embolic protection assembly 68 isexpanded to seal the inside circumference of the aorta. Expansion takesplace by moving the actuation sleeve 43 relative to the guidewire 41.All circulation through the aorta will hence have to be filtered in theporous bag 56 of the distal embolic protection assembly 68. Theguidewire 41 and actuation sleeve 43 extends from the proximal side ofthe distal embolic protection assembly 68 to the outside of the body 10and is accessible to the operator. In one embodiment of the presentinvention, the actuation sleeve 43 may also be used as a guidewire tomove the Scapus™ 46 into position. Thus in one embodiment of the currentinvention, the Scapus™ delivery system may be loosely disposed on aguidewire 41. In yet another embodiment of the present invention, theperfusion tube 49 functions as the actuation sleeve 43 to open andcollapse the distal embolic protection catheter.

Distal embolic protection assemblies 68 may be introduced through theapex 18 of the heart 12. Such embodiments are summarized in co ownedU.S. application Ser. No. 10/938,410, hereby incorporated by referencein its entirety. Distal embolic protection assemblies 68 may also beinserted through arteries such as the femoral artery such as thosedisclosed by Macoviak, et al in U.S. application Ser. No. 10/108,245,hereby incorporated for reference in its entirety. In another embodimentof the present invention, the distal embolic protection filter assembly68 is introduced through the femoral artery and moved to the aorticarch, positioned just downstream of the aortic valve as shown in FIG. 7.A delivery sheath 66 is used to collapse the filter assembly composed ofthe filter frame 55 and the porous bag 56. In a further embodiment ofthe current invention, a guidewire 65 is attached to the frame 55 on theproximal side of the filter assembly 68 and continues through the aorticvalve and out through the trocar 31 and out through the body 10. Theguidewire 65 may be used for guiding the delivery system 67 intoposition through the trocar 31 and the apex 18 of the heart. The way theguidewire 65 is attached to the mouth of the filter 55 is forillustrational purposes only. Anyone skilled in the art will appreciatethere are many different ways of attaching a guidewire to the mouth 55of the filter and different opening and closing mechanism for thefilter. Other aortic filter systems described in prior art for femoralartery insertion may also be adapted for this procedure.

In one embodiment of the current invention, the delivery sheath 66 shownin FIG. 7 is a Scapus™ 46 delivery system. The Scapus™ 46 deliverysystem may slide across the guidewire. The porous bag 56 may also beinserted and removed through the delivery system.

Once the distal embolic protection assembly 68 has been placed intoposition, the Scapus™ 46 of the delivery system 67 slides over theactuation sleeve 43 through the apex 18 of the heart 12. In oneembodiment of the present invention, the delivery system 67 slides overthe guidewire 41 or 65, depending on the configuration of the distalembolic protection assembly. The balloon delivery member 50 ispositioned in the aorta and within the aortic valve and aortic valveannulus. In one embodiment of the present invention, the distal embolicprotection system 68 and valve delivery system 67 is inserted throughthe apex 18 together.

A collapsed replacement heart valve prosthesis 100 is disposed on theballoon delivery member 50. The delivery system 67 with the attachedreplacement prosthetic valve slides over the actuation sleeve and isintroduced into the port of the access system 31 and through the apex 18of the heart 12. The balloon delivery member 50 with the attached heartvalve prosthesis 100 is positioned in the aorta and within the aorticvalve and aortic valve annulus. The balloon delivery member 50 isexpanded by moving fluid through the balloon inflation tube 45. Theballoon inflation tube 45 connects fluid to the balloon delivery member50. In one embodiment of the present invention, the device used to movefluid through the balloon inflation tube 45 is a syringe. The balloondelivery member 50 expands in a radial direction when filled with fluidthrough the balloon inflation tube 45 causing the replacement prostheticvalve 100 to exert force against the existing valvular leaflets and thewalls of the vessel.

In one embodiment of the present invention, the valve replacementprocedure described herein is done more than once. A repeat proceduremay, for example, be performed in patients who cannot tolerate an openchest surgery.

Once the heart valve prosthesis 100 is implanted, the balloon deliverymember 50 is deflated and the valve delivery system 67 is withdrawn fromthe body. The distal embolic protection assembly 68 is further withdrawnfrom the body 10. In one embodiment of the present invention, the distalembolic protection assembly 68 and the valve delivery system 67 arewithdrawn from the body together. In one embodiment of the presentinvention, a distal embolic protection assembly 68 is not utilized. Inyet another embodiment of the present invention, the distal embolicprotection assembly 68 is left in the body for some time (up to 7 days)after the operation to make sure that the porous bag 56 of the distalembolic filter assembly 67 has collected all the debris.

FIG. 8 shows an implanted heart valve prosthesis 100 positioned in theaortic valve position.

FIGS. 9, 10, and 11 show a Scapus™ delivery system comprising a Scapus™46, luer fitting 62, perfusion tube 49 and a dog-bone shaped balloondelivery member 50. The luer fitting 62 is attached to the proximal sideof the Scapus™ 46 and may be used to direct fluid for opening andclosing the balloon delivery member 50. The balloon delivery member 50is tightly disposed around the perfusion tube 49. The perfusion tube 49is attached to the Scapus™ 46. Fluid may flow through the luer fitting62, through the Scapus™ 46 and into the balloon delivery member 50 toinflate and deflate the balloon.

It is important to note that although the different inventions describedherein is typically described in reference to trans-apical valveimplantation, they may also be used in non-beating heart surgeries. AScapus™ delivery system, for example, may also be used in a open surgerysituation. Thus, in one embodiment of the current invention, a Scapus™delivery system is used in non-beating heart surgeries. In anotherembodiment of the current invention, a Scapus™ delivery system may beused in an open chest surgery or robotic surgery.

Converting a Catheter to a Scapus™: Systems and Methods Thereof

The preferred delivery system for delivering heart valves and tools in atrans-apical or trans-heart procedure is a Scapus™ delivery system. If aScapus™ delivery system is not available, however, one may convert acatheter into a delivery system that is similar to a Scapus™ deliverysystem.

In one embodiment of the current invention, a substantially thin, stiffguide stick is inserted into the catheter to give it similarcharacteristics as a Scapus™. The guide-stick is loosely disposed withinthe catheter and occupies the space that a guidewire would otherwiseoccupy. But as opposed to a guidewire that cannot resist bending, aguide-stick is substantially rigid and can resist any unintended bendingand torsion. A guide-stick disposed within a catheter, in contrast to acatheter by itself, provides sufficient rigidity such that the resultingdelivery system may more accurately and more precisely deliver aprosthesis during a beating heart procedure. The resulting deliverysystem is designed not to bend unless intended by the operator. Theresulting delivery system can incorporate junctions or other means ofbending at predetermined points to allow the operator to adjust thedirection or angle of the delivery path in a controlled fashion.

In another embodiment of the current invention, a substantially stiffguide-sleeve is loosely disposed on the outside of a catheter to give itsimilar characteristics as a Scapus™ delivery system. The catheter isloosely disposed within the delivery sleeve. The described deliverysleeve is substantially rigid and can resist any unintended bending andtorsion. A guide-sleeve loosely disposed on a catheter, in contrast to acatheter by itself, provides sufficient rigidity such that the resultingdelivery system may more accurately and more precisely deliver a heartvalve prosthesis 100 during a beating heart procedure. The resultingdelivery system is designed not to bend unless intended by the operator.The resulting delivery system can incorporate junctions or other meansof bending at predetermined points to allow the operator to adjust thedirection or angle of the delivery path in a controlled fashion.

Method for Valve Crimping and Valve Preparation

In one embodiment of the present invention, the heart valve prosthesis100 is shipped to the operating room in an expanded configuration. Theheart valve prosthesis 100 is crimped down in diameter using crimpersknown to anyone skilled in the art while the heart valve prosthesis 100is loosely disposed around a delivery member. The crimping processoccurs with the operating room or in vicinity of the operating room. Theheart valve prosthesis 100 is further delivered to the target site forimplantation.

In one embodiment of the current invention, the heart valve prosthesis100 is shipped to the operating room in a crimped configuration. Theheart valve prosthesis 100 is crimped at the manufacturing facility in acareful, consistent, and controlled manner. The heart valve prosthesis100 may be crimped directly onto a delivery member, such as a balloondelivery member 50. Alternatively, the heart valve prosthesis 100 may becrimped down to a size such that the internal diameter of the heartvalve prosthesis 100 matches the external diameter of the deliverymember. The heart valve prosthesis 100 remains in a crimpedconfiguration until the heart valve prosthesis 100 reaches the operatingroom. Crimping the heart valve prosthesis 100 in a controlledenvironment will minimize structural deterioration to the heart valveprosthesis 100 and will simplify the procedure in the operating room.When reaching the operating room, the crimped heart valve prosthesis 100is disposed around the delivery member, and the heart valve prosthesis100 is further delivered tot he target site for implantation.

Imaging Systems

Since a transapical procedure does not provide direct line of sight,sufficient imaging of the heart, valves, and other structures isimportant to provide diagnostics, guidance and feed-back during theprocedure. A Scapus™ delivery may be of a larger diameter than that of acatheter and is thus better suited for containing imaging transducers.Thus in one embodiment of the present invention, an imaging transduceris placed onto the delivery system. In one embodiment of the currentinvention, the imaging transducer is placed within the delivery member.In another embodiment of the present invention, the imaging transduceris placed just proximal and/or distal to the delivery member.

An external imaging transducer may be provided to view the operatingfield and imaging systems may be used at any time or throughout theduration of the surgery. The valvuloplasty assembly may include IVUS orother imaging sensors. Such imaging technology can be used to inspectnative valve annulus and size the required heart valve prosthesis 100after valvuloplasty has been completed.

Imaging systems are well-known to anyone skilled in the art and includetransesophageal echo, transthoracic echo, intravascular ultrasoundimaging (IVUS), intracardiac echo (ICE), or an injectable dye that isradiopaque. Cinefluoroscopy may also be utilized. The placement ofimaging probes in relation to a balloon delivery member 50 haspreviously been described in co-owned PCT/US/04/33026 filed Oct. 6,2004, incorporated by reference in its entirety.

Valve Removal System

The present invention also provides a method or system for removing thenative valve with a valve removal device by access through the apicalarea of the heart. By way of example, the valve removal may beaccomplished as taught in co-pending U.S. patent application Serial Nos.10/375,718 and 10/680,562, which are incorporated herein by reference asif set forth in their entirety.

In one embodiment of the present invention, the method may furthercomprise the step of removing at least a portion of the patient's heartvalve by means of a cutting tool that is disposed on the Scapus™. Inanother aspect of the present invention, the cutting tool may be made ofan electrically conductive metal that provides radiofrequency energy tothe cutting tool for enhanced valve removal. The high frequency energyablation is well known in the art.

In another embodiment of the present invention, the delivery memberincludes cutting means comprising a plurality of jaw elements, each jawelement having a sharp end enabling the jaw element to cut through atleast a portion of the native valve. In another aspect, the cuttingmeans comprises a plurality of electrode elements, whereinradiofrequency energy is delivered to each electrode element, enablingthe electrode element to cut through at least a portion of the nativevalve. In a further aspect of the present invention, the cutting meanscomprises a plurality of ultrasound transducer elements, whereinultrasound energy is delivered to each transducer element enabling thetransducer element to cut through at least a portion of the nativevalve.

A Scapus™ with a valve removal system disposed on it is introducedthrough the apex and positioned substantially in the vicinity of theaortic valve. The native valve leaflets and debris (e.g. calcium andvalve leaflets) are removed. The parts that are not contained by thevalve removal systems are caught in the distal embolic protectionfilter.

Distal Embolic Protection System

The present invention also provides for devices and methods forproviding distal embolic protection during the procedure. FIG. 5 andFIG. 6 show examples of distal embolic protection assemblies 68 and itsrelation to the delivery system 67. It is important that the distalembolic protection filter provides a means for trapping embolic materialand debris. In one embodiment, it is also desired that the distalembolic protection filter provides a temporary valve. The filter andtemporary valve assembly prevents flush back of blood, embolic materialand debris, while still allowing fluid flow into the filter duringsurgery. The temporary valve may also temporarily do the work of anadjacent heart valve, such as the aortic valve. Thus in one embodimentof the present invention, the distal embolic protection assembly 68provides a filter member for trapping embolic material that concurrentlyfunctions as a temporary valve.

Distal embolic protection assemblies 68 used in both trans-apical andpercutaneous procedures must be compressed and expanded to allow entryinto small blood vessels or other body cavities. Combining both aone-way valve and a filter basket mechanism requires a significantamount of hardware making it difficult to compress the filter downsufficiently to be used during trans-apical and percutaneous procedures.

FIG. 12 shows a sub-component of a distal embolic protection filtersystem that incorporates both a filter and the function of a temporaryvalve. The proximal mouth 73 of the filter consists of a proximal frame74 that pushes against and makes a seal with the surroundingvasculature. The proximal frame 74 may, for example, push and sealagainst the inner wall of the aorta, causing all emboli and debris toflow through the filter assembly. In one embodiment of the presentinvention, the proximal frame 74 is made out of a shape memory alloysuch as Nitinol, allowing it to expand into position.

The distal end 76 of the filter sub-assembly is shown open. In otherwords, debris not caught in the filter mesh 78 may continue out throughthe distal end 76 of the filter sub-assembly, moving past the distalframe 75. In one embodiment of the present invention, the distal frame75 is made out of a shape memory alloy such as nitinol, allowing it tomaintain an open configuration.

FIG. 13 shows three inter-connected filter sub-assemblies shown in FIG.12. Although three sub-assemblies are shown, any number of two or moresub-assemblies will work. The length from the proximal frame to thedistal frame of each sub-assembly is slightly different, thus separatingthe filters meshes of the different filter sub-assemblies 78, 79, and82. The proximal frame 74 is shared by all the different filtersub-assemblies.

Thus, in one embodiment of the present invention, a plurality of filtersub-assemblies are interconnected at the large inlet of the filters,while the downstream sides of the sub-assemblies have smaller openingsallowing debris to flow through. In one embodiment of the currentinvention, the outermost filter-assembly is closed at the downstreamend. As such, the device provides less flow restriction as the bloodflows into the porous bags (i.e. downstream from the aortic valve) asopposed to the reverse. This means that the device also functions as aone-way valve.

Valve Decalcification Systems

The formation of atherosclerotic plaques and lesions on cardiovasculartissue, such as blood vessels and heart valves, is a major component ofcardiovascular disease. A variety of different methods have beendeveloped to treat cardiovascular diseases associated with calcifiedatherosclerotic plaques and lesions. Such methods include mechanicalremoval or reduction of the lesion, such as bypass surgery, balloonangioplasty, mechanical debridement, atherectomy, and the valvereplacement.

Calcified atherosclerotic plaques and lesions may also be treated bychemical means which may be delivered to the affected area by variouscatheter devices. For example, U.S. Pat. No. 6,562,020 by Constantz etal., which is incorporated herein by reference as set forth in itsentirety, discloses methods and systems for dissolving vascularcalcified lesions using an acidic solution. A catheter delivers anacidic fluid to a localized vascular site. Such a system may, forexample, decalcify a calcified heart valve by applying an acidicsolution (such as hydrochloric acid, etc.)

The current percutaneous anti-calcification system disclosed byConstantz et al. is inserted through the femoral artery. Insertionthrough the femoral artery is impractical in the case of a trans-apicalprocedure as it requires another incision into the patient. The systemby Constantz et al. may be adapted such that the delivery membercontrolling and holding the decalcification system is moved from theproximal side (i.e. side of the operator as in the case of femoralaccess) to the distal side.

Accordingly, in another embodiment of the present invention, the methodsand devices of the present invention may be adapted to provide a valvedecalcification system, wherein a Scapus™ system is capable of providingthe dissolution solution to the treatment site by access through theapical area of the heart. Suitable dissolution solutions are known inthe art and are generally characterized as those which are capable ofincreasing the proton concentration at the treatment site to a desiredlevel sufficient to at least partially dissolve the mineral component ofa calcified atherosclerotic lesion.

A trans-apical delivered Scapus™ system may also provide means forisolating the treatment site to prevent the dissolution solution fromentering into the patient's circulatory system. Thus in one embodimentof the current invention the decalcification systems described andincorporated for reference above is adapted to be disposed on a Scapus™as opposed to a catheter. Such means for isolating the treatment sitemay include a barrier, such as a dual balloon system on the catheterthat inflate on both sides of the treatment site.

FIG. 14 shows such a delivery system where a multilumen Scapus™ 46connects to a perfusion tube 49 which in turn connects two balloons, aproximal balloon 92 and a distal balloon 93. The two balloons are showninflated and in intimate contact with the walls of the aorta 94. In oneembodiment of the present invention, the perfusion tube 49 is notpresent and the proximal balloon 92 and the distal balloon 93 areintimately in contact with the Scapus™ 43. Fluid may flow through theScapus™ 46 to inflate the proximal balloon 92 and distal balloon 93 aswell as provide the dissolution solution to the treatment site confinedby the proximal balloon 92 and distal balloon 93.

Valve Within Man-Made Valve: Systems and Methods Thereof

It is one objective of the current invention to provide systems andmethods for implanting an expandable heart valve within a target valvelocated within a heart. Such a procedure is beneficial in older ordiseased patients who have previously received a valve implant and whocannot or does not want to undergo the trauma of another open heartsurgery. Implanting an expandable heart valve within an existing targetheart valve allows the use of minimally invasive implantation techniquessuch as percutaneous of trans-apical valve implantation techniques.

The current methods and systems are distinctly different from Andersenet al. disclosed in U.S. Pat. No. 6,582,462 who describes theimplantation of a valve in a body channel or the vasculature. Andersen'sintent and objective is to describe an expandable valve that is placedwithin a body channel or vasculature and uses the intimate contactcreated within the vasculature, body channel, or native valve as supportto allow implantation. In the present invention, an expandable heartvalve prosthesis 100 is implanted within a previously implanted man-madeheart valve prosthesis and uses the intimate contact created with thepreviously implanted heart valve prosthesis for support. If thepreviously implanted heart valve prosthesis is removed, one willconcurrently remove the expandable heart valve prosthesis 100 locatedwithin the previously implanted heart valve prosthesis.

In one embodiment of the current invention, an expandable heart valveprosthesis 100 is mounted within a previously implanted heart valveprosthesis located within a heart. The expandable heart valve prosthesis100 may be any valve that can be delivered minimally invasively, such aspercutaneous or trans-apically delivered valves. In one embodiment ofthe current invention, the expandable heart valve prosthesis 100 is aballoon-expandable heart valve. In another embodiment of the presentinvention, the expandable heart valve prosthesis 100 is the 3F Entrata™heart valve. In another embodiment of the current invention, theexpandable heart valve prosthesis 100 is a self-expandable heart valve.In yet another embodiment of the present invention, the expandable heartvalve prosthesis 100 is a valve expanded using some other mechanical oractuating means.

The previously implanted heart valve prosthesis may be any valve eithernative or man-made. In one embodiment of the current invention, thepreviously implanted heart valve prosthesis is a mechanical valve. Inanother embodiment of the present invention, the previously implantedheart valve prosthesis is a tissue valve. The previously implanted heartvalve prosthesis may also be made out of polyurethane or be atissue-engineered valve. In one embodiment of the current invention, thepreviously implanted heart valve prosthesis can be an expandable heartvalve. In yet a further embodiment of the current invention, more thanone expandable heart valve prosthesis 100 may be implanted within apreviously implanted heart valve prosthesis. As such, multiple minimallyinvasive heart valve deliveries may be conducted without removing theexisting valve or existing valves. The previously implanted heart valveprosthesis may be an aortic valve, mitral valve, pulmonary valve, or atricuspid valve. The previously implanted heart valve prosthesis mayalso be a a homograft valve or a xenograft valve. Examples of previouslyimplanted heart valve prosthesis include, but are not limited to, theEdwards Perimount Valve, the Edwards BioPhysio Valve, the MedtronicHancock I Valve, the Medtronic Hancock M.O. Valve, the Medtronic HancockII Valve, the Medtronic Mosaic Valve, the Medtronic Intact Valve, theMedtronic Freestyle Valve, the St. Jude Toronto Stentless Porcine Valve(SPV), and the St. Jude Prima Valve.

The expandable heart valve prosthesis 100 may be made to fit well withinthe previously implanted heart valve prosthesis. In one instance, theposts of the expandable heart valve prosthesis 100 are coordinated tofit the posts of the previously implanted heart valve prosthesis. Thusin one embodiment of the present invention, the posts of the expandableheart valve prosthesis 100 matches the orientation for the posts of thepreviously implanted heart valve prosthesis. In one embodiment of thepresent invention, the inter-post separation angles of the expandableheart valve prosthesis 100 add up to 360°. In other embodiments of thepresent invention, the inter-post separation angle of the heart valveprosthesis 100 is 120°, 120°, and 120°; or 135°, 120°, and 105°; or135°, 105°, and 120°; or 120°, 135°, and 105°; or 120°, 105°, and 135°;or 105°, 135°, and 120°; or 105°, 120°, and 135°.

FIG. 15 shows an exploded view of FIG. 16 where a heart valve prosthesis100 is shown implanted within a previously implanted heart valveprosthesis 101. In a preferred embodiment, the inflow ring or annulus105 of the heart valve prosthesis 100 is aligned with the inflow ring orannulus 115 of the previously implanted heart valve prosthesis 101. Inanother preferred embodiment, the commissural posts 106 of the heartvalve prosthesis 100 is aligned with the commissural posts 116 of thepreviously implanted heart valve prosthesis 101.

It should be noted that although reference is made herein to a heartvalve 100 implanted into a previously implanted heart valve prosthesis101 inside the aorta, it is intended for such valve procedures toencompass any location within the heart 12, and not to be limited to theaorta.

In a preferred embodiment of the current invention, the previouslyimplanted heart valve prosthesis 101 is the same size or one size largerthan the expandable heart valve prosthesis 100. For purpose of example,if the previously implanted heart valve prosthesis 101 is 27 mm, theexpandable heart valve prosthesis 100 is either 25 mm or 27 mm in size.Thus, in one embodiment of the current invention, the expandable heartvalve prosthesis 100 is the same size as the previously implanted heartvalve prosthesis 101. In another embodiment of the current invention,the expandable heart valve prosthesis 100 is larger than the previouslyimplanted heart valve prosthesis 101. In another embodiment of thecurrent invention, the expandable heart valve prosthesis 100 is smallerthan the previously implanted heart valve prosthesis 101.

Clinical records will specify the exact size used during an earlierimplant. The size of the previously implanted heart valve prosthesis 101will thus be known. In-vitro tests will show the best size expandableheart valve prosthesis 100 for a specific size and type target valve.The optimal size expandable heart valve can thus be determined from theclinical records from the previous heart valve implant. Thus in oneembodiment of the present invention, the size of the expandable heartvalve prosthesis 100 to be used is determined from clinical records ofprior implants.

In one embodiment of the current invention, an expandable stent isimplanted within a previously implanted heart valve prosthesis 101 priorto implanting the expandable heart valve prosthesis 100. In anotherembodiment of the current invention, valvuloplasty is used to expand theorifice of the previously implanted heart valve prosthesis 101 beforeimplanting an expandable heart valve prosthesis 100 or before implantingan expandable stent.

Any delivery system may be used to deliver the expandable heart valveprosthesis 100. In one embodiment of the current invention, the deliverysystem is a catheter. In another embodiment of the current invention,the delivery system is a Scapus™. The expandable heart valve prosthesis100 may be delivered through any access point to the heart. In oneembodiment of the present invention, the expandable heart valveprosthesis 100 is delivered minimally invasively. In one embodiment ofthe present invention, the expandable heart valve prosthesis 100 isdelivered percutaneously. In another embodiment of the presentinvention, the expandable heart valve prosthesis 100 is deliveredtrans-apically.

Sutureless Valve Inserter System and Methods Thereof

The benefits of a Scapus™ valve delivery system may also be utilized inthe case of self-expandable valves. As such, the delivery system may beused for percutaneous valve delivery, trans-apical valve delivery,trans-heart delivery. In addition to these delivery techniques, theScapus™ delivery system may be utilized in more invasive cardiacprocedures such as open heart procedures.

The Scapus™ delivery system is well suited for delivering the 3F EnableAortic Heart Valve™ and the other valves described in co-owned U.S.applications entitled “Minimally Invasive Valve Replacement System” withthe following application Ser. Nos.: 10/680,733; 10/680,719; 10/680,728;10/680,560; 10/680,716; 10/680,717; 10/680,732; 10/680,562; 10/680,068;10/680,075; 10/680,069; 10/680,070; 10/680,071; and 10/680,567, allincorporated herein for reference in their entirety.

Sutureless Valve Inserter System and Methods Thereof

Current tissue heart valve replacements gradually calcify afterimplanted in the heart. Such is also the case when implantingreplacement heart valves in animals such as pigs or sheep. In fact,replacement heart valves intended for human use typically calcify fasterwhen implanted in animals such as pigs or sheep. Because of differencein flow dynamics, physiology, and biochemistry, the best performingcommercially available heart valves will typically show signs ofcalcification in pigs and sheep within 10-200 days. Standard animalmodels used for pre-clinical valve testing is frequently sheep, but pigsmay also be used. Adolescent sheep have great propensity to calcifybioprosthetic valves.

The fact that cardiac valves places in the heart of certain animalmodels calcify quickly may be used as basis for creating calcifiedanimal models for use in the development and testing of cardiac valves.

Open heart surgery valve replacement on adolescent sheep typicallyresults in less than 40% success/survival in the aortic position, owingto the very small valve sizes and the use of full bypass. Open heartsurgery valve replacement on adolescent sheep typically results in morethan 80% success/survival in the mitral position owing to the largervalve sizes and the use of beating heart, partial bypass. Placingreplacement valves in the mitral position during animal testing is notjust used to reduce costs but is also considered a “worst-case” positiondue to higher backpressures. Replacement aortic and mitral valves aretherefore frequently placed in the mitral position during animalstudies.

Accordingly, it is one object of the present invention to providemethods and systems for the creation of a calcified animal model.Commercially available tissue valves are first implanted in adolescentsheep. The animals are survived for 10-200 days and the performanceevaluated. Because of the increased propensity for calcification inanimals, all the valves implanted are expected to be stenotic and/orincompetent due to calcification of tissue leaflets. Sheep may beevaluated at regular intervals using echo.

It is another object of the present invention to utilize thecalcification model described above in the development and testing ofcardiac valves. Using either a percutaneous or trans-apical implanttechniques, place replacement heart valves within the calcified valvesof adolescent sheep. Survive the test animals for 20 weeks (150+/−10days) or as required by regulatory authorities. Monitor the replacementvalves. Necropsy, pathology, and post mortem histology may be performed.

The present invention may be divided into two phases:

-   -   I. Create a calcified animal model by replacing the native        valves of adolescent sheep with commercially available valves        and surviving the animals for 10-200 days.    -   II. Implant minimally invasive valves within the calcified valve        orifices using a minimally invasive valve procedure.

In phase I of the invention, a calcified animal model is created byreplacing the native valves of adolescent sheep with commerciallyavailable valves and surviving the animals. In one embodiment of thepresent invention, the heart valve replacement procedure is an on-pumpprocedure. In another embodiment of the present invention, the heartvalve replacement procedure is a minimally invasive heart valveprocedure, such as a percutaneous heart valve replacement procedure, ora trans-apical valve procedure. In the latter embodiment, the methoddescribed herein would allow testing of a minimally invasive heart valverepeat-procedure. In one embodiment of the current invention, the heartvalve replacement procedure is conducted endoscopically. In yet anotherembodiment of the current invention, the heart valve replacementprocedure is conducted using robots.

In one embodiment of the present invention, drugs are utilized to adjustthe rate of calcification. In another embodiment, the valve implantedduring Phase I is coated with a chemical substance used to adjust therate of calcification.

Any valve may be implanted during Phase I. In one embodiment of thepresent invention, the valve implanted is a tissue valve. In anotherembodiment of the present invention, the valve implanted is a mechanicalvalve. Implanted heart valves may include aortic valves, mitral valves,tricuspid valves, or pulmonary valves. A replacement valve may notnecessarily be implanted in its intended position. As an example, anaortic valve may be implanted in the mitral position of the animal. Thusin one embodiment of the present invention, a replacement aortic valveis implanted in the mitral position. In one embodiment of the currentinvention, multiple valves are implanted in different positions at thesame time.

In a preferred embodiment of the current invention, valves are implantedin animals whose heart physiology and flow dynamics, as well asbiochemistry, match humans as close as possible. Sheep and pigs are thusfrequently used for heart valve testing. Thus, in one embodiment of thecurrent invention, sheep is used as the animal model. In anotherembodiment of the current invention, pigs are used as the animal model.Any other primate may be used as an animal model. In one embodiment ofthe current invention, animals of subclass eutheria are used as theanimal model. In another embodiment of the current invention, animals ofthe suborder anthropoidea (e.g. monkeys and apes).

The age of an animal affects the rate of calcification. Thus, in oneembodiment of the current invention, the age of the animal is theequivalent of adolescence. In another embodiment of the currentinvention, the animals used are adults.

It is one object of the current invention to survive sufficient animalsto the end of Phase II such that pre-clinical regulatory requirementsare met for different regulatory bodies. It is expected that someanimals will not survive the valve replacements during phase I. Furtheranimals may perish during the duration of Phase I. Further animals willperish during the replacement implants during Phase II as well as duringthe duration of Phase II. In one preferred embodiment of the presentinvention, an excess number of animals are used to start Phase I suchthat sufficient numbers of animals are survived all the way throughPhase II. The exact number of animals needed for the start of Phase Idepends on numerous variables including the operator, the type ofanimal, the type of procedures.

It is one object of the current invention to monitor the progression ofcalcification and diseases related to implanted valves. Differentmonitoring equipment such as ultrasound, MRI, CT, and cinefluoroscopy,are used during the course of Phase I and Phase II. In one embodiment ofthe present invention, echo is used at 60, 90, and 120 days during PhaseI to monitor the implanted valves.

In one embodiment of the present invention, the animals in Phase I aresurvived for 90-120 days. The length of Phase I depends on factors suchas what type of animal used and what type of tissue valves used. Thevalves may be monitored during Phase I. It may be possible to go toPhase II earlier based upon in-vivo evaluation.

In Phase II of the invention, valves are implanted within the calcifiedvalve orifices. Implant procedures include, but are not limited tominimally invasive valve procedures, percutaneous valve procedures,trans-apical valve procedure, on-pump valve procedure, endoscopic valveprocedure, and robotic valve procedure.

In one embodiment of the present invention, drugs are utilized to adjustthe rate of calcification. In another embodiment, the valve implantedduring Phase II is coated with a chemical substance used to adjust therate of calcification.

Any valve may be implanted during Phase II. Tissue valves include, butare not limited to tissue valve, mechanical valves, aortic valves,mitral valves, tricuspid valves, pulmonary valves. A replacement valvemay not necessarily be implanted in its intended position. As anexample, an aortic valve may be implanted in the mitral position of theanimal. Thus in one embodiment of the present invention, a replacementaortic valve is implanted in the mitral position.

In one embodiment of the present invention, the animals in Phase I aresurvived for 20 weeks (150+/−10 days). The length of Phase II depends onguidelines provided by regulatory bodies.

In one embodiment of the current invention, the minimally invasive valvedelivery is conducted using a SCAPUS™ delivery system. In one embodimentof the present invention, the valve utilized is the 3F Therapeutics,Inc. Entrata™ valve. In one embodiment of the present invention, aballoon is used in the inferior vena cava to regulate pressure duringthe procedure.

In one embodiment of the current invention, the replacement valve inPhase II is seated within the calcified valve orifice of the valvereplacement conducted in Phase I. In another embodiment of the presentinvention, the replacement valve in Phase II is seated just upstreamfrom the calcified valve orifice of the valve replacement conducted inPhase I. In another embodiment of the present invention, the replacementvalve in Phase II is seated just downstream from the calcified valveorifice of the valve replacement conducted in Phase I.

Obviously, numerous variations and modifications can be made withindeparting from the spirit of the present invention. Therefore, it shouldbe clearly understood that the forms of the present invention describedabove and shown in the figures of the accompanying drawings areillustrative only and are not intended to limit the scope of the presentinvention.

1-52. (canceled)
 53. A delivery system comprising: an elongated, rigidsupport structure; a delivery member coupled to the support structure ata distal portion of the support structure; a valve replacementdetachably positioned about the delivery member and configured to becollapsed to temporarily reduce a valve diameter, the valve replacementcomprising a pliant prosthetic valve having an inlet end, an outlet end,a plurality of leaflet portions, and a plurality of commissural tabspositioned at the outlet end and integrally formed with the leafletportions; and a collapsible, self-expanding stent positioned about anexterior of the valve, the stent having a circular inflow rim and acircular outflow rim connected by a plurality of longitudinal supportposts, the commissural tabs operably coupled to the longitudinal supportposts, wherein the rigid support structure is configured to transmitlongitudinal and rotational motion along its length without twisting orbending along its length, wherein the delivery member comprises aperfusion tube connecting a distal end and a proximal end of thedelivery member configured to allow blood flow through the deliverymember, and wherein the rigid support structure terminates between theproximal end of the delivery member and the distal end of the deliverymember.
 54. The delivery system of claim 53, wherein the self-expandingstent comprises a shape memory alloy.
 55. The delivery system of claim54, wherein the shape memory alloy is Nitinol.
 56. The delivery systemof claim 53, wherein the rigid support structure is selected from thegroup consisting of a solid rod, a hollow rod, a catheter with a guidestick, and a catheter with a guide sleeve.
 57. The delivery system ofclaim 53, wherein the delivery member comprises a proximal portion, amiddle portion, and a distal portion, and wherein a cross-sectional areaof the proximal portion and a cross-sectional area of the distal portionare each greater than a cross-sectional area of the middle portion. 58.The delivery system of claim 57, wherein the valve replacement isdisposed about the middle portion of the delivery member.
 59. Thedelivery system of claim 53, wherein the valve replacement is configuredto be compressed to reduce the valve diameter by up to about 90%. 60.The delivery system of claim 53, further comprising a delivery sleevedisposed about the delivery member.
 61. A scapus delivery systemcomprising: an elongated, rigid scapus; and a delivery member positionedabout the scapus, wherein the delivery member comprises a perfusion tubeconnecting a distal end and a proximal end of the delivery memberconfigured to allow blood flow through the delivery member, and whereinthe scapus terminates between the proximal end of the delivery memberand the distal end of the delivery member.
 62. The delivery system ofclaim 61, further comprising a prosthetic valve positioned about thedelivery member, the prosthetic valve comprising: a collapsible,self-expanding stent; and a plurality of leaflets.
 63. The deliverysystem of claim 62, wherein the prosthetic valve is contained by thedelivery member.
 64. The delivery system of claim 62, further comprisinga delivery sleeve disposed about the delivery member.
 65. The deliverysystem of claim 61, wherein the scapus extends within the perfusiontube.
 66. A delivery system comprising: an elongated, rigid supportstructure; a perfusion tube attached to the support structure; adelivery member disposed around the perfusion tube; and a prostheticvalve positioned about the delivery member, the prosthetic valvecomprising: a collapsible, self-expanding stent; and a plurality ofleaflets; wherein the perfusion tube extends from a proximal end to adistal end of the delivery member and is configured to allow blood flowthrough the delivery member, and wherein the rigid support structureterminates between the proximal end and the distal end of the deliverymember.
 67. The delivery system of claim 66, wherein the prostheticvalve is crimped onto the delivery member.
 68. The delivery system ofclaim 66, further comprising a delivery sleeve disposed about thedelivery member.
 69. The delivery system of claim 66, wherein thesupport structure is attached to an exterior surface of the perfusiontube.
 70. The delivery system of claim 66, wherein the delivery membercomprises a proximal portion, a middle portion, and a distal portion,wherein a cross-sectional area of the proximal portion and across-sectional area of the distal portion are each greater than across-sectional area of the middle portion, and wherein the valvereplacement is disposed about the middle portion of the delivery member.71. The delivery system of claim 66, wherein the support structurecomprises a material that substantially resists bending and torsion. 72.The delivery system of claim 66, wherein the delivery member comprisesone or more holes at the proximal end and one or more holes at thedistal end to allow blood flow through the perfusion tube.